Drug Safety Specialist I

San Francisco, CA 94158 | Contract

Post Date: 03/01/2018 Job ID: 3941 Industry: Pharmaceutical

Our client is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates that utilize technology platforms, which are designed to improve the benefits of drugs for patients.

 

Duties:
  • Ensures compliance with standard operating procedures, Food and Drug Administration and ICH guidelines and regulations, and global regulations for the reporting of adverse events to regulatory agencies. 
  • Develops guidelines and insures the uniform and timely processing of adverse event reports. 
  • Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements. 
  • Develops and prepares reports for company management as well as external regulatory agencies.   
  • Assists in the preparation of safety updates for investigational new drug and new drug applications, investigator communications, product labeling/package inserts and other reports as necessary. 
  • May work with data management in the ongoing development of case report forms for clinical trials and maintenance of databases.
  • Performing complete data entry of serious adverse events received from clinical trials, according to the Company workflow processes and standard operating procedures.  
  • Generate initial case narratives based on information received as part of source documents including but not limited to, case report forms, hospital admission notes, history and physical (H&P) consult notes, progress notes, lab results, results of diagnostic, radiological and other tests, discharge summaries, death certificate and autopsy results provided by the study sites. 
  • Draft appropriate initial queries for outstanding information or incomplete data and communicate the queries to study site personnel following review and approval of the queries by a senior Company Drug Safety person. 
  • Communicate or notify the Company drug safety staff of issues related to case processing/coding, safety database and/or any other issues that impact case processing quality or timelines. 
  • Maintain and track all serious adverse events reported from the Company sponsored clinical trials for case processing relative to their priorities and submission deadlines.   
  • Support Drug Safety Department initiatives on ad hoc (as needed) basis.  
  • Adherence to global regulatory regulations and reporting timelines for all expedited serious adverse events. 
  • Maintain or track annual and/or periodic Pharmacovigilance regulatory submissions in USA and globally.  
  • Ensure compliance with the Company' s SOPs.

Skills:

  • Experience in oncology therapeutic area is preferred but not mandatory. 
  • Familiarity with Medical terminology required. 
  • Ability to process data entry accurately. 
  • Ability to code and map data accurately. 
  • Concise case narrative (medical) writing experience preferred. 
  • Ability to prioritize work without much support. 
  • Clear effective written and verbal communication skills are essential for effective communication with study sites. 
  • Focused and detail oriented. 
  • Work effectively as a team member, promote collaboration. 
  • Self starter and self accountability. 
  • Relevant industry experience is highly preferred. 
  • High level of work conduct.

 

Education:

  • A Bachelors degree in a scientific discipline is required.
  • RN or BSN degree is highly desired.
  • Equivalent experience may be accepted.
  • A minimum of two years experience in Drug safety or Pharmacovigilance, with at least one year’s hands-on experience in serious adverse event management in clinical trials evaluating investigational products is required.
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